Covance

  • EDC Validation Coordinator

    Job Location(s) IN-Bangalore
    Job Number
    2019-34697
    Job Category
    Biostatistics/Programming
    Position Type
    Full-Time
  • Job Overview

    • Development and implementation of solutions to global technical service issues and concerns regarding EDC tools like Medidata RAVE, Oracle InForm and SAS programming.
    • Read, understand and program EDC objects/SAS programming as per the specification documents which meets client requirements and projects.
    • Perform any post production changes to the EDC data base or enhancements to the SAS programs like SAS edit checks, listings, Reconciliation listings, Protocol Deviations, ACDR listings etc.
    • Perform publish checks, complex structure dynamics, RSG, Balance mapping settings.
    • Complete assigned work utilizing Medidata RAVE or Oracle InForm or SAS or other proprietary software according to Covance SOPs, Work Instructions ,and project specific guidelines in accordance with Good Clinical Practices
    • Provide suggestions and solutions to the operational issues.
    • Train the team on Rave or SAS as required and have them ready to perform the regular day to day activities.
    • Mentor the team to make them independent enough to perform day to day activities.
    • Perform quality check and ensure the work is delivered with 100% quality.
    • Prioritize personal workload to meet specified completion dates and perform work with supervision and direction from managers.
    • Maintain study databases for assigned projects and SAS programming as assigned by managers.
    • Perform all work with knowledge of regulations pertaining to computerized systems to projects to ensure compliance.
      • Ensure quality of personal work
      • Interact with project team members in related discipline e. g. Clinical Data Management, Clinical Operations and Data Management.
      • Display a positive attitude at all times, promoting and contributing to good team spirit in a professional environment
      • Continuously learn and improve communication and technical skills.
      • Attention to detail is essential and all tasks must be carried out to the highest standard.
      • Develop good problem solving skills and a willingness to learn and seek advice from senior Programming staff
      • Acquire knowledge of other aspects of the work of Programmer/Analyst under the supervision of the senior Programming staff
      • Carry out all activities according to Covance SOPs working within the framework of the Quality Management System and to Good Clinical Practice (GCP).
    • Perform other duties as assigned by Manager.

     

     

    Education/Qualifications

    • University/college degree (life science, computer science, programming, pharmacy or related subject preferred), or certification in a related profession from an appropriately accredited institution (e.g., nursing certification, computer science, medical or laboratory technology)

     

    • Good knowledge of drug development process and Clinical Data Management Programming.
    • Good knowledge of relational databases
    • Fluent in English, both written and verbal

    Experience

    • 5-7 years of relevant work experience to include data management and database support: EDC systems programming or SAS programming.
    • Good problem solving skills and a proactive approach
    • Good oral and written communication skills
    • Good knowledge of clinical trial process and data management, biometrics, and systems applications to support operations preferred
    • Ability to work in a team environment
    • Ability to work effectively under minimal supervision

     

    • Ability to prioritize work
    • Ability to mentor and train the team members.
    • Good time management skills and the ability to work to tight deadlines whilst maintain the highest standards of quality work
    • A cooperative and team oriented approach

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